ACRYSOF® SN6AT3 (REF SN6AT3.205)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof(R) IQ TORIC ASTIGMATISM IOL, SINGLE-PIECE ACRYLIC FOLDABLE LENS, UV WITH BLUE LIGHTFILTER, 13.0mm LENGTH, 6.0mm BICONVEX TORICASPHERIC OPTIC, 1.50 D CYLINDER. · Class 3 · Implant
All models of ACRYSOF (353)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652249904), received between Apr 30, 2021 and Sep 20, 2023 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Scratched Material3
- Adverse Event Without Identified Device or Use Problem2
- Material Split, Cut or Torn2
- Defective Device1
- Device Dislodged or Dislocated1
- Malposition of Device1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Visual Impairment3
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD REFRACTIVE SURPRISE/POOR VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17782234 ↗InjuryJun 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS BAD, INTERFERING WITH READING. THE IOL WAS EXCHANGED FOR ANOTHER LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION OF THE IOL / TORIC IOL MISALIGNED CAUSING HIGH ASTIGMATISM UNABLE TO REORIENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING, AS PER SURGEONS OPINION IOL WAS PLACED IN WRONG AXIS AND IOL POWER OFF BY 0.75D.
Patient problems: Visual Disturbances
MAUDE report 17199801 ↗MalfunctionMay 3, 2023Malposition of Device; Malposition of Device
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE AXIAL BEARINGS DID NOT MATCH THE IMPLANTATION AXIS (APPROX. 20°) AT THE CONTROL APPOINTMENTS. PATIENT HAD A RESIDUAL CYLINDER AND VISUAL DISABILITY. RELEVANT TESTS AND LAB DATA AS FOLLOW. PREOPERATIVE MEASUREMENTS: BCVA ((B)(6) 2023): 0.4 TO 0.6. POSTOPERATIVE MEASUREMENTS: BCVA ((B)(6) 2023): 0.4. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 16859499 ↗MalfunctionMar 14, 2023Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS SCRATCHED HENCE IT WAS REMOVED FROM THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16535538 ↗MalfunctionJan 15, 2023Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 16171585 ↗InjuryDec 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE LENS WAS INSIDE THE CAPSULAR BAG, THE HAPTIC TORN OFF SOMEWHERE IN THE MIDDLE. THE LENS WAS NOT FIXED IN THE CAPSULAR BAG AND NOT CENTERED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 16050830 ↗MalfunctionFeb 25, 2022Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON OBSERVED A SCRATCH, WHICH LOOKS LIKE FULL THICKNESS CIRCUMFERENTIAL DAMAGE ON THE IOL POST OPERATIVELY. SCRATCH LOOKS LIKE THE CURVED END OF THE PLUNGER. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT HAD A FULL THICKNESS TEAR IN HER LENS AT THE APPROX. 3 MM FROM CENTER OF THE IOL FORTUNATELY NO VISUAL SYMPTOMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13597413 ↗InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. MYOPIC SURPRISE WAS PROVIDED AS THE CLINICAL REASON FOR THE EXPLANT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 13202896 ↗MalfunctionAug 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SPLIT IN HALF AFTER INSERTION. THE LENS WAS REMOVED AND REPLACED AND PROCEDURE COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING, THE CAPSULAR BAG WAS INTACT SO LENS REPLACED WITH ANOTHER LENS OF SAME POWER. PATIENT DOESN¿T FORESEE ANY ONGOING CONCERNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12388271 ↗MalfunctionApr 30, 2021Scratched Material; Scratched Material
A NURSE REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS SCRATCHED AFTER IT WAS IMPLANTED INTO THE EYE. THE LENS WAS REMOVED IN THE SAME PROCEDURE AND REPLACED WITH A NEW LENS. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11752206 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page